Double-Blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00145327

Purpose

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 study (HORIZON Pivotal Fracture Trial).

Condition	Intervention	Phase
Osteoporosis	Drug: Zoledronic Acid Drug: Placebo Drug: Zoledronic acid	Phase III

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Zoledronic acid Calcium gluconate Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Three Years, Double-Blind Extension to CZOL446H2301 to Evaluate the Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

Further study details as provided by Novartis:

Primary Outcome Measures:

Percent change in bone mineral density (BMD) of femoral neck at year 6 relative to year 3

Secondary Outcome Measures:

Change from baseline of biochemical markers of bone turnover at different time points
Percent change from baseline in BMD of spine and distal radius at year 4.5 and 6
Percent change from baseline in BMD of femoral neck, total hip and trochanter at different time points
Proportion of patients with new vertebral fractures and incidence of clinical fracture
Bone biopsy to evaluate bone quality
Evaluation of safety parameters (renal function, laboratory parameters, AE profile)

Estimated Enrollment:	2480
Study Start Date:	June 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Zoledronic Acid
2: Placebo Comparator	Drug: Placebo
3: Experimental	Drug: Zoledronic acid

Eligibility

Ages Eligible for Study:	65 Years to 93 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

Poor kidney, eye, or liver health
Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145327

Show 30 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446H2301E1
Study First Received:	September 1, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00145327
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Osteoporosis, Zoledronic Acid

Study placed in the following topic categories:

Calcium, Dietary
Diphosphonates
Vitamin D
Zoledronic acid
Musculoskeletal Diseases
Fractures, Bone

Ergocalciferols
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009